# K080726: Calypso 4D Localization System

- Pathway: 510(k) (Traditional)
- Applicant: Calypso Medical Technologies, Inc.
- Decided: May 14, 2008 after 61 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K874787 (1987). 24 ancestors in all.
9 later devices descend from it; 5 cite it directly.
4 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060906: Calypso 4D Localization System, Calypso Medical Technologies, Inc. (2006)
- K031206: Radiomed Soft Tissue Marker, Radiomed Corp. (2003)

## Most influential descendants
- K102373: Calypso System with Dynamic Edge Gating (2010), 6 descendants of its own
- K112768: Calypso Systems with Dynamic Edge Gating (2011), 4 descendants of its own
- K123137: Calypso System (2012), 3 descendants of its own
- K140823: Permanent Beacon Transponder/Soft Tissue Beacon Transponder (2014), 2 descendants of its own
- K121663: Clarity (2012), 1 descendant of its own

## Indications for use
The Calypso® 4D Localization System is intended for use as an adjunct in treatment planning and radiation therapy, to align and monitor the patient's position relative to the isocenter of a linear accelerator. The Calypso® System provides accurate, precise and continuous localization of a treatment isocenter by using two or more Beacon transponders. Beacon® transponders are indicated for use to radiographically and electromagnetically mark soft tissue for future therapeutic procedures. Permanent Beacon® transponders are indicated for permanent implantation in the prostate and the peri-prostatic tissue (i.e., prostatic bed).

Source page: https://510kreport.com/device/K080726
Methodology: https://510kreport.com/methodology